Initial efficacy of anti-lymphocyte activation gene-3 (anti–LAG-3; BMS-986016) in combination with nivolumab (nivo) in pts with melanoma (MEL) previously treated with anti–PD-1/PD-L1 therapy.

• DOI: 10.1200/jco.2017.35.15_suppl.9520
• Publication Date: 2018-09-06T15:54:26Z
• Authors: Paolo Antonio Asc...; Ignacio Melero; Shailender Bhatia; Petri Bono; Rachel E. Sanborn; Evan J. Lipson; Margaret K. Callahan; Thomas Gajewski; Carlos A. Gomez-Roca; F. Stephen Hodi; Giuseppe Curigliano; Marta Nyakas; Matthias Preusser; Yoshinobu Koguchi; Matthew Maurer; Raphael Clynes; Priyam Mitra; Satyendra Suryawa...; Eva Muñoz-Couselo
• Keywords: Tolerability

9520 Background: Signaling via LAG-3 and other T-cell inhibitory receptors (eg, PD-1) can lead to dysfunction tumor immune escape. Simultaneous blockade of + PD-1 may synergistically restore activation enhance antitumor immunity. In a phase 1/2a study, BMS-986016 (IgG4 mAb targeting LAG-3) ± nivo demonstrated tolerability, peripheral activation, preliminary clinical activity (NCT01968109; Lipson E, et al. J Immunother Cancer. 2016;4[s1]:173 [P232]). Here we describe efficacy in pts with MEL whose disease progressed on/after prior anti–PD-1/PD-L1 therapy, along updated safety from all dose expansion pts. Methods: Pts must have had (± anti–CTLA-4 or BRAF/MEK inhibitors) progressive (PD). received 80 mg 240 IV Q2W. Primary objectives were objective response rate (ORR; complete [CR] partial [PR] response), control (DCR; CR uCR PR uPR stable [SD] > 12 wk), duration (RECIST v1.1). Results: At data cutoff, 43 been treated following PD known best responses 1 CR, 9 PR, SD, 16 PD. Of the pts, 30 (70%) also anti–CTLA-4, 20 (47%) ≥ 3 therapies, 15 (35%) BRAFmutations .In 31 efficacy-evaluable date, ORR was 16% (confirmed/unconfirmed) DCR 45% benefit observed even some refractory anti–PD-1. Evaluations are ongoing for most median treatment 10 wk Immunopathologic PD-1/PD-L1 expression) characteristics responders vs nonresponders will be presented. Any grade 3/4 treatment-related AEs occurred 46% 9%, respectively, across (n = 129). Conclusion: Addition nivolumab demonstrates encouraging initial profile similar monotherapy. Clinical trial information: NCT01968109.